The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Duet Dfa Rsv/respiratory Virus Screening Kit.
| Device ID | K081928 |
| 510k Number | K081928 |
| Device Name: | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Gail R Goodrum |
| Correspondent | Gail R Goodrum DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2008-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330899 | K081928 | 000 |
| 30014613330929 | K081928 | 000 |
| 30014613330912 | K081928 | 000 |
| 30014613330905 | K081928 | 000 |